clinical-trial-schema-designer

Community

Auto-generates CDISC schemas from protocols.

Authorjorgealves
Version1.0.0
Installs0

System Documentation

What problem does it solve?

The Clinical Trial Schema Designer automates the creation of CDISC-compliant data structures (SDTM/ADaM) from clinical protocols, reducing manual data modeling effort and speeding up study design and submission preparation.

Core Features & Use Cases

  • Automated CDISC domain mapping from protocol inputs to standard domains (e.g., VS, DM, AE).
  • Schema generation aligned with FDA/PMDA standards for SDTM and ADaM.
  • Use Case: Design data ingestion pipelines for multi-source studies to streamline regulatory submissions.

Quick Start

Provide the protocol text and select the target CDISC standard (SDTM/ADaM/CDASH) to generate a ready-to-use data schema and mapping logic.

Dependency Matrix

Required Modules

None required

Components

Standard package

💻 Claude Code Installation

Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.

Please help me install this Skill:
Name: clinical-trial-schema-designer
Download link: https://github.com/jorgealves/agent_skills/archive/main.zip#clinical-trial-schema-designer

Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
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